Balloon catheter tip design

ABSTRACT

The present invention is directed to distal tip designs for catheter, wherein distal tip material is positioned about an inner shaft. The distal tip material may also be used as a tie layer for thermally bonding two incompatible materials together, such as a waist portion of a balloon to the inner shaft.

BACKGROUND OF THE INVENTION

The present invention is related generally to medical devices. Morespecifically, the present invention is related to catheters. The presentinvention includes the bonding of incompatible catheter elements to oneanother and distal tips for catheters, including balloon angioplastycatheters and stent delivery catheters, and methods of making them.

Arterial blockages, which are also called stenoses, are typically causedby the build-up of atherosclerotic plaque on the inside wall of anartery. In fact, several such stenoses may occur contiguously within asingle artery. This can result in a partial, or even complete, blockageof the artery. As a result of the danger associated with such ablockage, several methods and procedures have been developed to treatstenoses. One such method is an angioplasty procedure which uses aninflatable balloon to dilate the blocked artery. A typical inflatableangioplasty device, for example, is disclosed in U.S. Pat. No.4,896,669.

Catheters are frequently used to carry and deploy stent at target siteswithin vessels. Stents have come into increasing use to prevent thewidened vessel regions from narrowing after angioplasty. A stent,typically having a tubular shape, can be put in place in the widenedvessel region to hold the vessel walls apart and the lumen open in theevent the vessel attempts to narrow again. One class of stents requiresthat the stent be forcibly outwardly expanded to put the stent intoposition against the vessel walls. Another class of stents,self-expanding stents, can be delivered to a site in a compressed orconstrained configuration and released in the vessel region to besupported. The self-expanding stent then expands in place to aconfiguration having a wide lumen, typically pressing firmly against thevessel walls where released. The stent is commonly placed at a recentlydilated, stenosed vessel region.

Size and construction of a catheter is usually dictated by the purposefor which they are used. Vasculature targets are usually difficult toreach requiring a device which can navigate tortuous conduits of varyingdiameter. As such, certain characteristics are commonly desired. Ingeneral, a catheter should have a maximum radial extent or profile nolarger than necessary, in part to enable the catheter to reach furtherinto narrower vessel regions. Desirable features further include, butare not limited to, flexibility, trackability and adequate columnstrength, accuracy and ease of use, ease of manufacture and materialswhich cause minimal damage to the vasculature.

Typically, balloon catheters include, among other elements, a shaft, aballoon mounted thereon and a relatively soft distal tip, used topromote tracking and to reduce damage. Different parts or elements ofcatheters are typically bonded together via thermal bonding or adhesivebonding. It is to these issues that the present application is generallydirected, taking into consideration general desired features of catheterdesign and construction.

All US patents and applications and all other published documentsmentioned anywhere in this application are incorporated herein byreference in their entirety.

Without limiting the scope of the invention a brief summary of some ofthe claimed embodiments of the invention is set forth below. Additionaldetails of the summarized embodiments of the invention and/or additionalembodiments of the invention may be found in the Detailed Description ofthe Invention below.

A brief abstract of the technical disclosure in the specification isprovided as well only for the purposes of complying with 37 C.F.R. 1.72.The abstract is not intended to be used for interpreting the scope ofthe claims.

BRIEF SUMMARY OF THE INVENTION

The present invention is generally directed to catheter tip and cathetershaft designs for balloon catheters, as well as construction of suchdesigns wherein thermally incompatible materials are being used.

In certain embodiments of the invention, the distal tip is mountedaround the distal end of an inner shaft. Soft distal tip material, suchas Pebax® resins (polyether-block co-polyamide polymers) and nylon has atendency to soften when introduced into the body due the increase intemperature. The softening of the material increases the frictionbetween the guide wire and the inner wall of the distal tip. The softmaterial gets “sticky” causing the catheter to get hung up on the guidewire. This impedes guide wire movement through the catheter. Mountingthe material around the inner shaft reduces the contact between the tipmaterial and the guide wire.

A further aspect of the invention includes having the tip materialbutted up to the distal waist of the balloon and over the inner shaft.This provides for a more flexible tip because the inner shaft and thetip material are more flexible than the waist of the balloon. This alsoallows for a shorter waist, improving flexibility.

A further aspect of the invention is that a small amount of the distalend of the distal tip may overhang the distal end of the inner shaft.This allows for a lower introductory profile and for more robustnesswhen being tracked in the anatomy. The overhang can be between 0-7 mmbeyond the distal end of the inner shaft. The optimal design woulddepend on what properties one is trying to achieve. The shorter theoverhang, the better the wire movement, whereas the more the overhang,the better flexibility. The amount of tip overhang may be varied toachieve different performance results.

The invention also contemplates an inner shaft which circumferentiallyis stepped down at its distal end. This allows the inner shaft toreceive the distal tip material without increasing the profile, creatinga smoother profile.

The invention also contemplates using the distal tip material as a tielayer to facilitate the bonding of two materials which are ordinarilyconsidered to be incompatible for thermal bonding. The most notableexample described herein is the use of a tie layer to facilitate thebonding of the waist of a balloon to an inner shaft, wherein the tielayer also forms a distal tip. The distal end of the inner shaft mayalso be necked down to minimize the profile. These tie layers may alsobe used in facilitating bonding of other parts of the catheter where twoincompatible materials are being used.

The invention contemplates the above mentioned features alone or invarious combinations to achieve desired features of catheter design andconstruction.

These and other embodiments which characterize the invention are pointedout with particularity in the claims annexed hereto and forming a parthereof. However, for a better understanding of the invention, itsadvantages and objectives obtained by its use, reference should be madeto the drawings which form a further part hereof and the accompanyingdescriptive matter, in which there is illustrated and described aembodiments of the invention.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

A detailed description of the invention is hereafter described withspecific reference being made to the drawings.

FIG. 1 is a cross-sectional representation of an embodiment of theinvention showing the distal end region of a catheter.

FIG. 1 a is a cross-section of FIG. 1 shown along lines 1 a-1 a.

FIG. 2 is a cross-sectional representation of an embodiment of theinvention showing the distal end region of a catheter.

FIG. 3 is a side perspective view of the distal end of an embodiment ofthe inner shaft.

FIG. 4 is a side perspective view of the distal end of an embodiment ofthe inner shaft.

FIG. 5 is a cross-sectional representation of an embodiment of theinvention showing the distal end region of a catheter.

FIG. 6 is a cross-sectional representation of an embodiment of theinvention showing the distal end region of a catheter.

FIG. 7 is a cross-sectional representation of an embodiment of theinvention showing the distal end region of a catheter.

FIG. 8 is a cross-section view of FIG. 5 along lines 8-8.

FIG. 9 is a cross-sectional representation of an embodiment of theinvention showing the distal end region of a catheter.

FIG. 10 is a cross-sectional representation of an embodiment of theinvention showing the distal end region of a catheter.

FIG. 11 is a cross-sectional representation of an embodiment of theinvention showing the distal end region of a catheter.

FIG. 12 is a cross-sectional representation of an embodiment of theinvention showing the distal end region of a catheter.

FIG. 13 is a cross-sectional representation of an embodiment of theinvention showing the distal end region of a catheter.

FIG. 14 is a cross-sectional representation of an embodiment of theinvention showing the distal end region of a catheter.

FIG. 15 is a cross-sectional representation of an embodiment of theinvention showing the distal end region of a catheter.

FIG. 16 is a cross-sectional representation of an embodiment of theinvention showing the distal end region of a catheter.

FIG. 17 is a cross-sectional representation of an embodiment of theinvention showing the bonding of a proximal balloon waist.

DETAILED DESCRIPTION OF THE INVENTION

While this invention may be embodied in many different forms, there aredescribed in detail herein specific embodiments of the invention. Thisdescription is an exemplification of the principles of the invention andis not intended to limit the invention to the particular embodimentsillustrated.

For the purposes of this disclosure, like reference numerals in thefigures shall refer to like features unless otherwise indicated.

In the description of the inventive catheters of the presentapplication, the figures used only illustrate the distal end of atypical catheter. It should be understood that the tip designs of thepresent application may be incorporated and used in the construction ofany conventional catheter. It also should be understood that the figuresare graphic representations of the inventive catheter designs and shouldnot be construed to represent actual dimensions.

As indicated above, the present invention is embodied in a variety offorms. FIG. 1 is a cross-section representation of the invention showingthe distal end of a balloon catheter 10. The balloon catheter 10includes an inner shaft 12 defining a lumen 14. A balloon 16 having awaist portion 18 is secured to the inner shaft 12 by conventional means.A distal tip 20 is further secured to the distal end 22 of the innershaft 12. The proximal end 24 of the distal tip 20 abuts the waistportion 18 of the balloon 16. A space 27 may be between the proximal end24 and the distal tip 20 and the waist portion 18 of the balloon 16.

The distal end 26 of the distal tip 20 overhangs the distal end 22 ofthe inner shaft 12. The margin 30 of overhang may vary. The overhang maybe 0-7 mm. In some specific embodiments, the margin 30 is about 0.5 mmto 1.0 mm.

The balloon 16 is secured to the inner shaft 12 through conventionalmeans, including, but not limited to, laser welding and adhering.

The distal tip 20 is secured to the distal end 22 of the inner shaft 12by laser welding, adhesive bonding or heat shrinking. Adhesive bondingis well known. Examples of thermal bonding can be founding U.S.application Ser. No. 09/654,987.

This overhanging tip design provides, among other benefits, for betterguide wire (not shown) movement through the inner shaft 12 lumen 14.Less distal tip material comes in contact with the guide wire thanconventional distal tip designs. The present designs also provide moreflexibility in the catheter. This, in part, is due to the reduction inlength of the distal waist of the balloon.

A comparison was conducted illustrating the improved guide wire movementand flexibility. Results are shown in Tables A and B. The catheterconfiguration used for sample #'s 1-4 is shown in FIG. 1. The tips ofsamples 1-2 overhang the inner shaft by 11.0 mm and the tips of samples3-4 overhang the inner shaft by 0.5 mm. The catheter configuration usedin sample #'s 5-14 is the design of the Maverick 2™ sold by BostonScientific. For samples # 5 and #6, the balloon's distal waist wasground by 25%. These samples otherwise had the identical configurationas the 2.5 mm balloon distal waist group. Sample #'s 7-14 have varyingballoon distal waist lengths.

Table A is the spring rate of the tip when tracked around a tight bend.The lower the spring rate the easier it is to navigate the curve. TableB is the peak force (grams) required to track the curve. The lower theforce the more flexible the tip is. If you look at Table B, you see thatthe ground balloons require the least amount of force to track aroundthe curve. TABLE A (grams/cm) Description # Run 1 Run 2 Run 3 Average1.0 mm Tip overhang 1 84.9 79.3 80.8 81.7 1.0 mm Tip overhang 2 87.083.7 80.5 83.7 0.5 mm Tip overhang 3 63.2 62.4 60.2 61.9 0.5 mm Tipoverhang 4 56.6 57.1 63.8 59.2 25% Ground Balloon 5 78.9 77.5 77.1 77.825% Ground Balloon 6 78.4 71.3 75.8 75.2 2.5 mm Balloon waist 7 108.398.5 95.6 100.8 2.5 mm Balloon waist 8 109.4 97.4 105.3 104.0 3.5 mmBalloon waist 9 102.5 103.4 104.8 103.6 3.5 mm Balloon waist 10 102.995.4 93.5 97.3 4.5 mm Balloon waist 11 105.2 99.1 94.2 99.5 4.5 mmBalloon waist 12 103.1 112.7 110.1 108.6 2.5 mm Balloon waist 13 86.974.3 78.2 79.8 5.5 mm Balloon waist 14 100.0 86.7 86.5 91.0

TABLE B (grams) # Run 1 Run 2 Run 3 Run 4 1 57.0 50.5 47.8 51.8 2 61.754.2 53.7 56.5 3 62.4 53.8 52.9 56.3 4 55.2 51.6 50.6 52.4 5 51.9 47.847.3 49.0 6 48.9 45.8 45.2 46.7 7 74.3 65.3 63.6 67.7 8 72.3 67.1 65.368.2 9 72.3 66.9 63.9 67.7 10 78.5 74.2 72.2 75.0 11 76.3 68.9 65.6 70.312 76.7 70.7 70.1 72.5 13 81.6 74.3 74.5 76.8 14 81.4 73.7 72.3 75.8

The amount of tip overhang may be varied to achieve differentperformance results. With a given peak force to track around a curve,you can adjust your tip length to change your effective spring rate ofthe tip.

The inner shaft 12 may comprise two or more layers of material, whichmay be co-extruded to form the shaft 12. FIG. 1 a shows a possiblecross-section of the inner shaft 12. The inner layer 13 may be formed ofa lubricious material, such as, but not limited to, high densitypolyethylene, while the outer layer 15 may comprise material such as,but not limited to, Pebax™ (polyamide-polyether-polyester blockcopolymer). The inner shaft 12 may also have a middle layer, such asPlexar® (anhydride modified linear low density polyethylene) between thepolyethylene layer and the Pebax™. The middle layer compatibly bondswith both the inner 13 and outer layer 15. It should be understood thatthe inner shafts of the various embodiments shown and discussed may bemultilayered.

A further illustration of the invention is depicted in FIG. 2, whichshows a cross-section representation of the distal end of a ballooncatheter 32. In this representation, the inner shaft 12 is a multilayershaft formed from an inner layer 34 and an outer layer 36. The innerlayer 34 in one embodiment is a tube of polyethylene. Other materialsinclude nylons, such as Grilamid™ (nylon 12), Pebax™ and Hytrel®(thermoplastic polyester elastomer). The outer layer 36 is extruded, orotherwise applied, onto the inner layer 34 by conventional means. Itshould be understood, as mentioned above that the layers may beco-extruded. The outer layer 36 in one embodiment is a hard Pebax®material (polyamide-polyether-polyester block copolymer 63D, 66D, 68D,70D and 72D), or may be Hytrel™ and other Nylon 12's, such as Grilamid™.The inner shaft 12 has a necked-down portion 38, wherein the distal end22 inner shaft 12 is ground down to receive the softer distal tip 20.The distal tip 20 material in one embodiment is a soft Plexar®, Pebax®(55D-72D) or nylons, such as Grilamid™. In this representation of theinvention, the distal tip 20 distally terminates approximately flushwith the inner shaft 12, however, it should be understood that, asdescribed above, the distal tip 20 may extend beyond the inner shaft 12.The distal tip material 20 may flow and be drawn out distally during theheating process producing a sloping or narrowing tip, as shown in FIG.2.

Also, in this representation shown in FIG. 2, the proximal end 24 of thedistal tip abuts the waist portion 18 of the balloon 16, which issecured to the outer layer 36 of the inner shaft 12, via conventionalmeans.

FIGS. 3-4 show a further aspect of the invention. As shown, the innerlayer 34 of the inner shaft 12 may be cut 40 or scored to reduce surfacecontact with the guide wire and to increase flexibility. The cut may bea spiral cut, as shown in FIG. 3, or several parallel circumferentialcuts may be made (not shown). The adjacent ribbon portions may be incontact, as shown in FIG. 3, or they may be separated, as shown in FIG.4. This cutting or scoring may also be done to the waist portion(s) 18of the balloon 16, either partially or substantially along the entirewaist.

FIGS. 5-17 illustrate further representations of the invention. Inaddition to the features described above, in these representations, thedistal tip 20 further acts as a tie layer between the balloon waist 18and the inner shaft 12. A tie-layer acts in bonding two materials,typically two incompatible materials, together via laser welding, orother thermal bonding methods. For example, a balloon made of PET(polyethylene terephthalate) and an inner shaft made of Pebax® do noteasily, covalently bond to one another. A tube of distal tip materialmay act as a tie-layer sleeve or a “compatibilizer”, wherein the outerlayer or surface of tie-layer would be compatible with the balloonmaterial and the inner layer would be compatible with the inner shaftmaterial. In this particular example, a tie-layer sleeve is a two layersleeve made of EMS (EA20HV1 Grilamid: EA-Nylon 12 (modified) 20-mediumviscosity HV1-Adhesion (modified)) and Hytrel® (polyether-estercopolymer) by Du Pont Co. The tie-layer sleeve is coextruded to form atube with an outer layer made of Hytrel®, which is compatible with PET,and an inner layer made of EMS, which is compatible with Pebax®. The tielayer may also be applied in the form of a liquid by spraying,microdrop, dip or otherwise applying the liquid to the substrate. Apowder tie layer, as seen in U.S. application Ser. No. 10/055,743, filedJan. 23, 2002, is also contemplated. The distal tip layer could also befrom a tube with material removed through punched or laser cutholes/slots.

The materials of the layers of the tie layer are dictated by thematerial of the elements which are to be bonded. The side of the tielayer which faces each element would be compatible therewith. The tielayer need only be one layer if the material of the one layer iscompatible with both of the elements which are to be bonded. When tocompatible materials are bonded together thermally, they are covalentlybonded, as apposed to being mechanically bond or molecularly entangledwith one another. Such bonds of the invention have minimal delaminationand resist peel. The bonds of the present invention substantiallycomprise covalent connections between the two materials being bonded.Two incompatible layers which are thermally bonded together do not formcovalent bonds substantially over the surface area of the bonded area.Rather, entangled or mechanical bonds are formed, which aren't as strongas covalent bonds.

The bonds created in the present invention allows one to connect aballoon to an inner shaft, wherein the balloon material is incompatiblewith the outer layer of the inner shaft, an create a balloon catheterwhich resists peal between the balloon 16 and the inner shaft 12, whilethe balloon is under pressure in excess of 309 psi.

The following are further representations of the present invention, someutilizing a distal tip sleeve as a tie-layer. Some configurations arerepetitive as far as configuration of the examples discussed above. Theysimilarly are cross-sectional representations.

In FIG. 5, the distal tip 20 is positioned in the necked-down 38 portionof the inner shaft 12. The waist 18 of the balloon 16 is secured ontothe proximal portion of the distal tip 20. As mentioned above, thebonding of the layers may be achieved through conventional means,including, but limited to, laser welding, heat shrinking and adhering.

The distal tip material 20 is pushed or heat shrunk onto the necked-downportion of the inner shaft 12. The waist 18 of the balloon 16 is thenheld in place over the tip material 20. The layers may be individuallyadhered or they may be thermally bonded. A tip is thus formed having, asseen in FIG. 8, a thin harder inner layer 34 and a soft outer layer 20.The tip material 20 is used as a tie layer securing the waist portion 18of a balloon to the inner shaft 12. Such an arrangement improves theintegration of the inner shaft, balloon and the soft tip. Due to thenecked-down portion of the inner shaft 12, the profile is minimized.

FIG. 6's representation of the invention is the same as the one showedin FIG. 5 except that the distal tip 20 material is circumferentiallystepped up 44 such that there is a smoother transition from the outersurface of the balloon waist 18 to the outer surface of the distal tip20. Also, as shown 19, the distal tip material 20 may extend proximallyfrom the balloon waist 18.

FIG. 7's representation of the invention is same as the one showed inFIG. 6 except that the distal tip 20 extends distally beyond the end ofthe inner shaft 12. This may occur during the heating process, wherebythe tip material flows, extending itself distally, as mentioned above,or the tube of tip material may just be longer.

FIG. 9 shows the tie-layer 50, which, as mentioned above, may be the tipmaterial 20, about the distal end of the inner shaft 12, extendingdistally forming the distal tip 50. The waist 18 of the balloon 16 isabout the proximal end of the tie-layer 50. The three overlapping layers52 are thermally bonded. In this embodiment, the ends of the inner shaft12 and the balloon waist 18 are substantially radially aligned. As withthe other embodiments, if the distal tip material 50 is not compatiblewith the balloon material 16 and the outer surface of the inner shaft12, a fourth layer may be added in the overlapping region 52 to tiewhatever contacting layers which are not compatible.

FIG. 10 shows a further representation which is the same as shown inFIG. 9, except that in the region of the three overlapping layers 52,the inner shaft 12 is necked down, as described above. As can be seen,the tie layer 50 overhangs the inner shaft 12. The waist 18 may alsoextend proximately from the necked down portion 38 of the inner shaft12, as shown. In this embodiment, the end of the inner shaft 12 mayextend further than the balloon waist 18. Such a construction moves apotential focal neck region out of the functional area. Thermalprocessing of extruded tubes removes orientation, which in turn reducespoint of yield strength.

FIG. 11 shows an embodiment, wherein the tie layer's 50 distal endterminates prior to the distal end of the inner shaft 12 and balloonwaist 18 ends at or prior to the distal end of the tie layer 50.

FIG. 12 shows an embodiment, wherein the inner shaft 12 terminates at,or prior to, the distal end of the tie layer 50 and wherein the balloonwaist 18 extends beyond the distal end of the tie layer 50.

FIG. 13 shows an embodiment, wherein the tie layer 50 extends proximallyfrom the proximal end of the balloon waist 18. Also, the inner shaft 12terminates at or prior to the distal end of the tie layer 50 and the tielayer 50 terminates at or prior to the distal end of the balloon waist18.

FIG. 14 shows an embodiment, wherein the balloon waist 18 is bonded tothe inner shaft 12 via a tie layer 50. Abutting the distal end of thetie layer 50 is a distal tip 20, which may be of a material which isdifferent than the tie layer 50 material, wherein the distal tip 20 isabout the inner shaft 12 and extends distally beyond the distal end ofthe inner shaft 12. It should be understood that the distal tip layer 20may be thicker to provide a flush transition from the balloon waist 18and further it may thermal drawn out to provide a sloping and narrowingtip.

FIG. 15 shows the balloon catheter of FIG. 9, except that the innershaft 12 extends beyond the waist 18 of the balloon 16. As can be seen,the tie layer 50 extends beyond the distal end of the inner shaft 12.

FIG. 16 shows an embodiment, wherein a separate distal tip 66 abuts thedistal end of the inner shaft 12. The tie layer 50 facilitates theconnection between the inner shaft 12 and the distal tip 6 as well asthe bonding of the waist 18 to the inner shaft 12. As can be seen in thefigure, there may be a small gap between the distal end of the innershaft 12 and the proximal end of the distal tip 16.

FIG. 17 illustrates a further use of the tie layer 56. In thisrepresentation, the tie layer 56 is facilitating the bond between theproximal waist 58 of the balloon 16 to a distal outer shaft 62. In thisparticular figure a inner shaft 64.

The application of a compatibilizer sleeve or tie layer is also usefulin other applications where two materially incompatible elements orjoints are to be securely joined together so as to enable laser weldingand advanced bonding technologies. These designs enable numerousmaterials to be thermally welded irrespective to their compatibility andallow greater flexibility in choosing designs of catheters. Furtherapplications include, but are not limited to, proximal bonds, mid-shaftbonds, manifold bonds, steel blade bonds and port weld bonds oncatheters.

It should also be understood that grinding a given percent of theballoon waists to remove mass enhances the performance characteristicsof the tip designs in such areas as flexibility, trackability,pushability and profile. Such grinding techniques can be found in U.S.Pat. No. 6,193,738. As mentioned above, the balloon waists may cut orscored.

To repeat those mentioned above or in addition to the ones mentionedabove, the distal tip 20/50 material may be made of any suitable softsuitable material including, but not limited to, nylons, such asGrilamid® ELY 2694 (tensile modulus 65,250 psi) produced by EMS-ChemieHolding AG/American Grilon, Inc. of Sumter, S.C.,polyamide-polyether-polyester block copolymers, such as Pebax® 7033(flexural modulus 67,000 psi, hardness 72D, but as low as 40D),polyether-ester copolymers, such as Amitel® by DSM Engineering Plastics,polyether-ester copolymers, such as HYTREL by Du Pont Co., high densitypolyethylene (HDPE), EMS, a polyamide/Arnitel™ blend, and PE anhydridePlexar™ and mixtures thereof. In one embodiment, the distal tip materialhas a flexural modulus from about 67,000 to about 29,000 psi and ahardness from about 55D to 70D. A low durometer Nylon/Grilamid™ materialmay be used.

When the distal tip material is being used as a tie layer, as mentionedabove, the tie layer material is dictated by the materials which are tobe bonded together. Suitable materials include, but are not limited to,are the ones listed above. Examples of incompatible materials which mayuse a tie layer for thermal bonding include, but art not limited to,HDPE and Pebax, Arnitel and PET, PET and Pebax, PTFE and Pebax. Anexample of a tie layer would be a double layer sleeve, wherein one layeris EMS and one layer is Hytrel™ or Arnitel™.

To repeat materials mentioned above or in addition to the ones mentionedabove, the inner shaft may be made of any suitable material including,but not limited to, HDPE, polyamide-polyether-polyester blockcopolymers, such as Pebax® 7233, polyetherether ketone (PEEK),polyether-ester copolymers, and PTFE (polytetrafluoro-ethylene). Asmentioned above the inner shaft 12 may be formed of multiple layers,which may be coextruded. An example of a three layer inner shaft wouldbe an inner shaft having a Pebax™ outer layer, a PE inner layer and aPlexar™ middle layer sandwiched between the outer and inner layers.

The balloon body 16 may be made of any suitable balloon materialincluding compliant and non-compliant materials and combinationsthereof. Some examples of suitable materials for constructing theballoon body 18 include but are not limited to: low pressure, relativelysoft or flexible polymeric materials, such as thermoplastic polymers,thermoplastic elastomers, polyethylene (high density, low density,intermediate density, linear low density), various co-polymers andblends of polyethylene, ionomers, polyesters, polyurethanes,polycarbonates, polyamides, poly-vinyl chloride,acrylonitrile-butadiene-styrene copolymers, polyether-polyestercopolymers, and polyetherpolyamide copolymers; copolymer polyolefinmaterial available from E.I. DuPont de Nemours and Co. (Wilmington,Del.), under the trade name Surlyn™; ionomer and a polyether block amideavailable under the trade name PEBAX™; high pressure polymericmaterials, such as thermoplastic polymers and thermoset polymericmaterials, poly(ethylene terephthalate) (commonly referred to as PET),polyimide, thermoplastic polyamide, polyamides, polyesters,polycarbonates, polyphenylene sulfides, polypropylene and rigidpolyurethane; one or more liquid crystal polymers; and combinations ofone or more of any of the above.

It should be understood that the embodiments and methods discuss hereinmay apply to any vascular system of any size.

The above devices may be constructed using a laser welding process toproduce the distal balloon bonds. As an example, a tie layer tube iscoextruded, such as an EMS/Hytrel™ tube. The EMS/Hytrel™ tube may thenbe necked and thereafter cut to length forming the tie layer sleeve. Aballoon assembly is then provided and the tie layer sleeve is thenpositioned. The assembly is then held in place via a heat shrink layer.The assembly is then laser welded to form the finished assembly.

The above disclosure is intended to be illustrative and not exhaustive.This description will suggest many variations and alternatives to one ofordinary skill in this art. All these alternatives and variations areintended to be included within the scope of the claims where the term“comprising” means “including, but not limited to”. Those familiar withthe art may recognize other equivalents to the specific embodimentsdescribed herein which equivalents are also intended to be encompassedby the claims.

Further, the particular features presented in the dependent claims canbe combined with each other in other manners within the scope of theinvention such that the invention should be recognized as alsospecifically directed to other embodiments having any other possiblecombination of the features of the dependent claims. For instance, forpurposes of claim publication, any dependent claim which follows shouldbe taken as alternatively written in a multiple dependent form from allprior claims which possess all antecedents referenced in such dependentclaim if such multiple dependent format is an accepted format within thejurisdiction (e.g. each claim depending directly from claim 1 should bealternatively taken as depending from all previous claims). Injurisdictions where multiple dependent claim formats are restricted, thefollowing dependent claims should each be also taken as alternativelywritten in each singly dependent claim format which creates a dependencyfrom a prior antecedent-possessing claim other than the specific claimlisted in such dependent claim below.

This completes the description of the alternate embodiments of theinvention. Those skilled in the art may recognize other equivalents tothe specific embodiment described herein which equivalents are intendedto be encompassed by the claims attached hereto.

1. A catheter comprising, a shaft, the shaft having a proximal portion,a distal portion, the distal portion terminating at a distal end, and aconduit there through, a distal tip layer, the distal tip layer being inthe form of a tube and being positioned about the distal portion of theshaft, the distal tip layer having a proximal end and a distal end,wherein the distal end of the distal tip layer extends distally to atleast the distal end of the shaft, the catheter further comprising amedical balloon, the balloon having a body portion position between aproximal waist and a distal waist, wherein the distal waist is connectedto the distal portion of the shaft and is positioned at least adjacentto the proximal end of the distal tip layer.
 2. The catheter of claim 1,wherein the distal end of the distal tip layer distally extends beyondthe distal end of the shaft.
 3. The catheter of claim 1, the distal endof the shaft having a first longitudinal portion having a first diameterand a second longitudinal portion having a second diameter, the secondlongitudinal portion being immediately adjacent to the firstlongitudinal portion, wherein the first diameter is greater than thesecond diameter, the second longitudinal portion forming acircumferentially stepped down portion from the first longitudinalportion, wherein the distal tip layer is positioned around thecircumferentially stepped down portion.
 4. The catheter of claim 3,wherein the shaft comprises a first layer and a second layer, the secondlayer being about the first layer, wherein the first layer and thesecond layer are made out of different materials.
 5. The catheter ofclaim 4, wherein the second layer comprises Pebax and the first layercomprises polyethylene.
 6. The catheter of claim 4, wherein the firstlayer is cut.
 7. The catheter of claim 6, wherein the cut is a spiralcut.
 8. The catheter of claim 7, wherein a spiral space is formed by thespiral cut.
 9. The catheter of claim 4, the first layer having aplurality of circumferential cuts.
 10. The catheter of claim 2, whereinthe distal end of the distal tip layer distally extends no more than 1mm beyond the distal end of the shaft.
 11. The catheter of claim 2,wherein the distal end of the distal waist abuts the proximal end of thedistal tip layer.
 12. The catheter of claim 2, wherein there is a gapbetween the distal waist and the distal tip layer.
 13. The catheter ofclaim 1, wherein the distal tip layer is between the distal waist andthe shaft.
 14. The catheter of claim 3, wherein the proximal end of thedistal tip layer abuts the distal waist.
 15. The catheter of claim 3,wherein the distal tip layer is between the distal waist and the shaft.16. The catheter of claim 13, wherein the distal end of the distal tiplayer distally extends beyond the distal end of the shaft.
 17. Thecatheter of claim 16, wherein the distal tip layer extends no more than7 mm beyond the shaft.
 18. The catheter of claim 15, wherein the distaltip layer is circumferentially stepped to receive the distal waist. 19.The catheter of claim 13, wherein the distal tip layer is a tie layerand wherein the distal waist, the shaft and the tie layer are thermallybonded together.
 20. The catheter of claim 15, wherein the distal tiplayer is a tie layer and wherein the distal waist, the shaft and the tielayer are thermally bonded together.
 21. The catheter of claim 19,wherein the distal waist and the shaft are incompatible for thermalbonding.
 22. The catheter of claim 19, wherein the distal waist and theshaft are incompatible for thermal bonding.
 23. A catheter comprising, ashaft, a first tubular layer about the shaft and a second tubular layerabout the shaft, the shaft and the first and second tubular layers beingthermal bonded together, the first tubular layer having an inner sideand an outer side and being at least partially between the secondtubular layer and the shaft, wherein the second tubular layer and theshaft are incompatible for thermal bonding with one another.
 24. Thecatheter of claim 23, the shaft having a proximal portion, a distalportion, the distal portion terminating at a distal end, and a conduitthere through, the first tubular layer being positioned about the distalportion of the shaft, the second tubular layer being a medical balloon,the balloon having a body portion positioned between a proximal waistand a distal waist, wherein the distal waist is thermally bonded to thefirst tubular layer and the first tubular layer is thermally bonded tothe shaft.
 25. The catheter of claim 24, wherein the outer side of thefirst tubular layer is compatible for thermal bonding to the distalwaist and the inner side of the first tubular layer is compatible forthermal bonding to the shaft.
 26. The catheter of claim 23, wherein thefirst tubular layer comprises a layer of EMS and a layer of Hytrel orArnitel.
 27. The catheter of claim 24, wherein the first tubular layercomprises a layer of EMS and a layer of Hytrel or Arnitel.
 28. Thecatheter of claim 24, wherein the shaft extends distally beyond thedistal waist and the first tubular layer.